NLNK stock is moving higher on December 20, 2019 after the company announced that the FDA approval of ERVEBO has triggered a voucher from Merck.
NewLink Genetics Corporation (NASDAQ:NLNK) announced today that, after priority review, the FDA has granted approval of ERVEBO®, or Zaire Ebola virus vaccine V920 (rVSV∆G-ZEBOV-GP), as confirmed by our partner, Merck (NYSE:MRK), known as MSD outside the US and Canada. This represents the first vaccine approved by the FDA for the Ebola virus and follows the November 11th grant by the European Commission (EC) of a marketing authorization for ERVEBO® across 31 European countries.
Yesterday’s approval comes almost three months prior to the Prescription Drug User Fee Act (PDUFA), or target FDA action date, originally set for March 14, 2020. As NewLink has previously stated, the FDA’s approval of this Ebola vaccine will trigger the issuance of a priority review voucher (PRV) owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink will have the right to monetize its share of interest in the voucher.
“We are delighted by the FDA’s decision to approve this Ebola vaccine and by the agency’s recognition of the potential this vaccine may offer to protect individuals who may be exposed to Ebola from contracting this deadly disease,” commented Eugene Kennedy, MD, Chief Medical Officer and member of NewLink Genetics’ Office of the CEO. “We are grateful to our partner Merck, and to the regulatory bodies involved, for their dedication to advancing solutions to combat this deadly illness.”
NewLink Genetics (NLNK) announced that, after priority review, the FDA has granted approval of Ervebo, or Zaire Ebola virus vaccine V920, as confirmed by the company’s partner, Merck (MRK). This represents the first vaccine approved by the FDA for the Ebola virus and follows the November 11 grant by the European Commission of a marketing authorization for Ervebo across 31 European countries, the company added. As NewLink has previously stated, the FDA’s approval of the Ebola vaccine will trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics “has a substantial economic interest.”